Research Fraud Probe Leads to Criminal Charge

by John Gever John Gever,Senior Editor, MedPage Today
January 15, 2010

A Massachusetts anesthesiologist accused of fabricating data in studies of pain drugs will plead guilty to federal criminal charges under an agreement with prosecutors.

Scott Reuben, MD, a well-known pain researcher at Baystate Medical Center in Springfield, Mass., was charged with one count of healthcare fraud.

Early last year, the hospital announced that an internal audit had revealed that Reuben had made up research data out of whole cloth, affecting at least 21 published studies over a 15-year period. (See Special Report: Few Gaps in Analgesic Practice After Reuben Retractions) The criminal charge arose from one of those studies, funded by Pfizer and published in Anesthesia & Analgesia in 2007.

According to the U.S. Attorney's office in Boston, Pfizer had given some $74,000 to Reuben for a placebo-controlled study of celecoxib (Celebrex) as part of a "multimodal" painkiller regimen for outpatient knee ligament surgery. The study was to enroll 100 patients.

Reuben subsequently reported to Pfizer and in the journal article that 200 patients entered the trial and that the celecoxib regimen was effective.

"In fact, Reuben had not enrolled any patients into that study, and the results reported both to Pfizer and to Anesthesia & Analgesia and, in turn, to the public were wholly made up by Reuben and therefore false," prosecutors wrote in a court filing.

Reuben could receive up to 10 years of jail time, to be followed by three years of supervised release and a $250,000 fine, but prosecutors agreed in the plea deal to recommend penalties at the low end of the range allowed in sentencing guidelines.

The agreement also requires Reuben to pay a total of about $362,000 in restitution to Pfizer and other pharmaceutical companies, plus $55,000 in fines and forfeitures.

Last year, after Baystate announced its findings on Reuben, the 21 articles it identified as tainted were retracted by the journals publishing them.

The National Library of Medicine's PubMed system lists more than 70 articles published since 1991 with Reuben as an author. The 21 retracted articles all listed Reuben as first author.

The editor of one journal that had published Reuben's research, Regional Anesthesia and Pain Medicine, contacted other investigators on six studies in which Reuben was a secondary author.

They all attested to the truthfulness of the reported data, according to the journal editor, Joseph M. Neal, MD. The journal ended up retracting only the one paper which had Reuben as lead author.

Reuben's contract with Baystate was terminated last March, at which time he reportedly also agreed with the state's medical board to voluntarily withdraw from practice.